QC Analyst II

NEUROTECH U S A • Cumberland, RI

5h

About The Position

Neurotech Pharmaceuticals, Inc. is a private biotech company located in Cumberland, RI and Needham, MA, within the realm of Greater Boston’s vast biotechnology landscape. Since our inception more than 20 years ago, our focus has been on developing and commercializing transformative therapies for chronic eye diseases. The core platform technology, Encapsulated Cell Therapy (ECT), is a first-in-class drug delivery platform designed to slow the progression of chronic eye diseases. Neurotech’s first commercial product, ENCELTOTM (revakinagene taroretcel-lwey), is approved in the United States for the treatment of adults with idiopathic Macular Telangiectasia Type 2 (MacTel). Encapsulated cell-based gene therapy is designed to provide long-term, sustained delivery of therapeutic proteins for the treatment of chronic eye diseases.  The Quality Control (QC) Analyst II – Technical Services plays a key role within Neurotech’s Quality Control Technical Services (QCTS) group, providing technical and operational support to ensure reliable supply and control of analytical reagents, assay controls, and reference standards. The Analyst II is responsible for hands-on preparation, qualification, and maintenance of these materials to support ongoing GMP release and stability testing within the QC Analytical group. This position will also support cross-functional laboratory projects in collaboration with Commercial Sciences, including method development, method transfer, and new product testing initiatives. The role offers opportunities for technical growth and contribution to continuous improvement initiatives that strengthen the QC infrastructure supporting Neurotech’s commercial and clinical programs. Please note, this role is not eligible for agency recruiting support. Additionally, Neurotech does not accept unsolicited résumés or candidate profiles. If a candidate submitted in this manner is hired, no placement fee will be paid.

Requirements

• Bachelor’s degree in Biology, Biochemistry, Biotechnology, or related scientific discipline.
• 3–6 years of experience in a GMP Quality Control or Analytical Development environment, preferably within biologics, cell therapy, or gene therapy.
• Strong understanding of analytical reagent preparation, handling, and control material management.
• Working knowledge of cGMPs, GLPs, and Good Documentation Practices.
• Excellent organizational and technical documentation skills.
• Ability to work independently while collaborating effectively across departments.

Nice To Haves

• Experience with bioassay or cell-based assay execution strongly preferred.
• Prior experience with LIMS, eQMS, or similar laboratory data systems a plus.

Responsibilities

• Execute daily QCTS operations including preparation, qualification, labeling, and inventory management of reference standards, assay controls, and reagents.
• Maintain accurate and traceable documentation in accordance with GDP and GMP requirements.
• Perform qualification or suitability testing of control materials under established methods and specifications.
• Support QC Analytical team by ensuring timely availability and delivery of all required testing materials.
• Participate in cross-functional laboratory studies supporting method development, method improvement, and method transfer activities.
• Assist in drafting and revising technical documents such as SOPs, test methods, and qualification protocols.
• Execute investigations, deviations, and change controls related to reagent or control system issues, under supervision.
• Maintain laboratory compliance and readiness for regulatory inspection through adherence to cGMP practices and data integrity standards.
• Identify opportunities for process improvement within QCTS workflows and propose enhancements to documentation, material control, or scheduling systems.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 51-100 employees